UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030392 |
|---|---|
| Receipt number | R000034259 |
| Scientific Title | Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2023/03/03 11:42:41 |
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Basic information
Public title
Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride
Acronym
The DUET study
Scientific Title
Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride
Scientific Title:Acronym
The DUET study
Region
| Japan |
Condition
Condition
Secondary hyperparathyroidism
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of achievement of more than 50% reduction and under 240pg/dl in intact parathyroid hormone (iPTH) after 12 weeks of treatment
Key secondary outcomes
-Ratio of achievement of 60<=iPTH<=240 after 12 weeks of treatment
-Ratio of achievement of more than 30% reduction in iPTH after 12 weeks of treatment
-Ratio of achievement of more than 30% reduction and 60<=iPTH<=240 after 12 weeks of treatment
-Ratio of achievement of more than 50% reduction in iPTH after 12 weeks of treatment
-Change in iPTH after 2, 4, 6, 8, 10 and 12 weeks of treatment relative to the baseline
-Change in CalciProtein Particle (CPP) and Fibroblast Growth Factor 23 (FGF23) after 6 and 12 weeks of treatment relative to the baseline among treatment groups
-Change in Ca, P, CaXP and Mg after2, 4, 6, 8, 10 and 12 weeks relative to the baseline among treatment groups
-Change in Bone Specific Alkaline Phosphatase (BAP) and Tartrate-resistant Acid Phosphatase 5b (TRACP5b) after one year of treatment relative to the baseline among treatment groups
-Comparison of aortic calcification before and after observation
-Ca, P and iPTH levels after one year of treatment
-Comparison of normalized ratio of hypocalcemia between VitD and calcium preparations
-Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Etelcalcetide+active Vitamin D for 12weeks
Interventions/Control_2
Etelcalcetide+oral calcium (calcium carbonate) for 12weeks
Interventions/Control_3
Control [active Vitamin D + oral calcium (calcium carbonate)] for 12weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.patients on maintenance hemodialysis 3 times a week
2.patients with more than one-year hemodialysis vintage
3.patients who are judged stable
4.older than 20 years and younger than 100 years
5.iPTH >=240 pg/ml within 4 months
6.corrected Ca >=8.4mg/dl at enrollment
7.patients who are able to write informed consent
Key exclusion criteria
1.patients who have been prescribed etelcalcetide before
2.bisphosphonate users within 24 weeks
3.primary hyperparathyroidism
4.undergoing parathyroidectomy or intervention therapy to parathyroid within 90 days before enrollment
5.scheduled parathyroidectomy, intervention therapy to parathyroid or kidney plantation
6. pregnant or breast feeding
7. patients who are deemed unsuitable by a physician, for instance cancer, severe infection and severe complication
8. patients who are prescribed Maxacalcitol, over 10[micro]gx3/week at obtainment of IC
9. patients who are prescribed Calcitriol, over 0.75[micro]gx3/week at obtainment of IC
10. patients who are prescribed other active VitD, over half of maximum dose at obtainment of IC
11. patients who are prescribed precipitated calcium carbonate, over 3g/day at obtainment of IC
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Maruyama |
Organization
Nagoya University Graduate School of Medicine, Internal Medicine
Division name
Nephrology
Zip code
4648550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
+81-52-744-2192
marus@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Sawako |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine, Internal Medicine
Division name
Nephrology
Zip code
4648550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
+81-52-744-2192
Homepage URL
Kato07@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Nephrology
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65 Tsurumai Showa Nagoya
Tel
052-741-2111
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
120
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034259
